In many areas of the world most severely affected by the HIV/AIDS pandemic, insect and water-borne diseases such as malaria and diarrheal disease are common causes of illness and death. In addition, diarrhea and malaria are more common and more severe among adults and children infected with HIV. These infections may modulate the immune system, affect the replication of the HIV virus and could result in more rapid HIV disease progression in co-infected individuals. Access to practical, inexpensive and easy to use interventions to prevent these diseases may be effective in delaying HIV progression.

Current Kenya government and World Health Organization guidelines recommend the use of cotrimoxazole (trimethoprim-sulfamethoxazole [TMP/SMX]) to prevent co-infections, including malaria. Despite the provision of TMP/SMX to HIV-infected adults, infections with malaria and pathogens causing diarrhea remain common causes of morbidity and mortality in many resource-limited settings. In addition, TMP/SMX may not prevent all infections with malaria or other pathogens due to alternative mechanisms of action, antimicrobial resistance and non-compliance due to adverse events or other reasons.

We propose a study to evaluate the impact of providing insecticide treated bednets and a simple water filtration device on markers of HIV disease progression among a cohort of ART naïve, HIV infected adults prescribed TMP/SMX in Kenya. In addition, we propose to evaluate the effect of these interventions on malaria and diarrheal disease incidence and on compliance with TMP/SMX.

To determine the effect of LLIN and a simple microbiological water purification system on markers of HIV progression (time to HAART eligibility and changes in CD4 counts) among antiretroviral naïve, HIV infected adults in Kenya. [ Time Frame: Mass screening and enrollment in July 2009, followed by two years of follow-up, and up to a year of data analysis. ] [ Designated as safety issue: No ]

PRIMARY AIM (Aim 1): To determine the effect of the intervention, we will evaluate the effect of the provision of LLIN and water filters on markers of disease progression at 12 months. We will compare the time to eligibility for ART between the groups and the time to CD4 counts of less than 200 and 350 respectively using Cox regression analysis models. In addition, we will compare differences between the mean change in CD4 counts at month 12 of follow-up using ANCOVA controlling for baseline CD4 values.

Secondary Outcome Measures:

To determine the effect of LLIN and a simple microbiological water purification system on the incidence of malaria and reported diarrheal disease when added to the standard regimen of TMP/SMX among antiretroviral naïve, HIV infected adults in Kenya. [ Time Frame: Same as primary outcome. ] [ Designated as safety issue: No ]

Aim 2: To determine the effect of the intervention on the incidence of diarrheal disease and malaria parasitemia, we will compare the frequency of reported diarrheal illness and documented parasitemia between the intervention and comparison groups using poisson regression or generalized estimating equation model.

To determine the durability of provision of an LLIN and a simple microbiological water purification system on markers of disease progression up to 24 months among antiretroviral naïve, HIV infected adults in Kenya. [ Time Frame: Same as primary outcome ] [ Designated as safety issue: No ]

Aim 3: To determine the durability of the intervention, we will evaluate the effect of the provision of LLIN and water filters on markers of disease progression up to 24 months. We will compare the time to eligibility for ART between the groups and the time to CD4 counts of less than 200 and 350 respectively using Cox regression analysis models. In addition, we will compare changes in mean CD4 counts overtime between the groups using linear mixed effects models controlling for baseline values.

Cohort 1 is the intervention group who received long-lasting insecticide treated bednets and a water filtration device

Other: Bednets and Water Purification

Individuals in the intervention cohort will be provided with a LLIN and water filtration device. Subjects are followed for 24 months and have serial measurements of HIV disease progression. Data are collected every 3 months on the frequency of malaria, diarrhea and other co-morbidities, as well as compliance with LLIN and water filter use.

Comparison

Cohort 2 is the comparison group included from the control arm of the study, "Empiric therapy of helminth coinfection to reduce HIV-1 disease progression" ClinicalTrials.gov identifier: NCT00507221

As part of the RCT (NCT00507221), we have enrolled 948 HIV infected ART naïve individuals to compare HIV disease progression in those receiving standard of care versus empiric deworming. Subjects are followed for 24 months and have serial measurements of HIV disease progression, and are evaluated serially for evidence of malaria, diarrhea and other co-morbidities. Participants in this study will have been consented for the collection of data on the frequency of malaria and diarrheal disease, their use of a bednet and water filtration and their compliance with TMP/SMX.

The study will compare markers of HIV disease progression among ART naive individuals receiving LLIN and a simple microbiological water purification system to the control arm of the randomized controlled trial being conducted at the same clinic settings (NCT00507221).

Criteria

Inclusion Criteria:

Participants must be at least 18 years of age.

Participants must not be or have ever been on highly active antiretroviral therapy CD4 count at enrollment of ≥350 cells/mm3

WHO Stage I or II or Stage III based on pulmonary TB only and have completed 2 months of first-line therapy.

Participants must be able and willing to participate and give written informed consent

Participants must be able and willing to return for the scheduled follow-up visits

Participants must not be pregnant at the time of enrollment (by urine HCG testing)

Patients with active tuberculosis who are on second or third line therapy or have not completed at least 2 months of first line TB therapy (Participants who have completed two months of first line TB therapy will be eligible for enrolment)

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00914225